Lead connector, lead adapter, and lead insertion apparatus

ABSTRACT

A connector and adapter engage leads with each other or with an implantable medical device when a wedge is removed from the spring-loaded connector or adapter assembly, thereby permitting the connector or adapter to compress around the lead connector. The connector and adapter assembly may include a body with at least one lumen, at least one contact exposed within the at least one lumen of the body, at least one wire electrically connected to the at least one contact, at least one clamp ring capable of compressing around the body, and at least one wedge or similar tool capable of opening and closing the at least one clamp ring.

This application is a divisional of U.S. patent application Ser. No.10/741,412, filed Dec. 19, 2003, which claims the benefit of U.S.Provisional Patent Application Ser. No. 60/439,168, filed Jan. 9, 2003,both of which are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to leads for use with implantableneurostimulation devices, and more particularly relates to connectorsand adapters for connecting leads for use with implantableneurostimulation devices.

BACKGROUND OF THE INVENTION

The typical interconnection between an Implantable Pulse Generator (IPG)or other neurostimulation device and the stimulating and/or sensing leadtakes up a considerable amount of volume in an IPG body. Because IPGbodies are implanted inside a patient's body, it is critical to minimizethe size of the IPG. Hence, it is important to minimize the size of thetypical interconnection between an IPG and a lead.

Further, many contemporary lead interconnections require additionaltools to form a connection during surgery. The use of complicatedadditional tools during surgery increases the risk of human error duringoperation, complicates the operation by requiring additional steps tocomplete a procedure, and can add time to already time sensitiveprocedures.

Therefore, a need exists for a connector or adapter that forms aminimally-sized interconnection between leads and/or between a lead andan IPG that is located outside the IPG body and that requires noadditional tools to complete the interconnection during operation.

SUMMARY OF THE INVENTION

The present invention addresses the above and other needs by providing anovel design of a minimally-sized connector and a minimally-sizedadapter that connect leads to each other or to an IPG device (such as aspinal cord stimulator or a deep brain stimulator) and require noadditional tools to form a stable electrical connection.

The design of the connector allows for coupling of a lead array with theimplantable stimulation device outside the IPG device body, therebyminimizing the IPG size. The connector is firmly connected to the IPGdevice at the connector's proximal end, and the connector's distal endis used for connection with the lead or lead extension. The distal endof the connector includes a lumen in which a plurality of metal ringsmay be linearly arranged in a resilient body of the connector. Theconnection of the lead with the implantable device takes minimal space.The design of the adapter allows connection between multiple leads orlead extensions, even those from different manufacturers. The method ofengaging a lead with the connector or the adapter is a very simple andquick procedure that does not require any additional tools such as ascrewdriver or a hex wrench.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other aspects of the present invention will be moreapparent from the following more particular description thereof,presented in conjunction with the following drawings wherein:

FIG. 1 is an isometric view of an IPG, a female connector, an extensionlead, a female/female adapter, and a stimulation lead;

FIG. 2A is an isometric view of a female connector;

FIG. 2B is an isometric view of a female/female adapter;

FIG. 3 is an exploded isometric view of the elements of a femaleconnector assembly;

FIG. 4 is an exploded isometric view of the elements of a female/femaleadapter assembly;

FIG. 5A is an isometric view of a female connector body;

FIG. 5B is an isometric view of a female/female adapter body;

FIG. 6 is an isometric view of a metal contact;

FIG. 7 is an isometric view of a clamp ring;

FIG. 8 is an isometric view of a wedge tool or insertion apparatus;

FIG. 9A is an isometric view of a female connector assembly and a lead;

FIG. 9B is an isometric view of a lead inserted into the lumen of afemale connector assembly;

FIG. 9C is an isometric view of a female connector engaged with a leadand a wedge tool of the present invention removed;

FIG. 9D is an isometric view of a female connector electrically andmechanically engaged with a lead;

FIG. 10A is an isometric view of a female/female adapter assembly andtwo leads;

FIG. 10B is an isometric view of two leads inserted into the lumen of afemale/female adapter assembly;

FIG. 10C is an isometric view of a female/female adapter engaged withtwo leads and two wedge tools of the present invention removed;

FIG. 10D is an isometric view of a female/female adapter electricallyand mechanically engaging two leads;

FIG. 11 is an isometric view of a female connector attached to an IPG;

FIG. 12 is a side view of a lead extension with a female connector ofthe present invention;

FIG. 13 is an isometric view of a female/male adapter of the presentinvention; and

FIG. 14 is an isometric view of a female/female adapter.

Corresponding reference characters indicate corresponding componentsthroughout the several views of the drawings.

DETAILED DESCRIPTION OF THE INVENTION

The following description is of the best mode presently contemplated forcarrying out the invention. This description is not to be taken in alimiting sense, but is made merely for the purpose of describing thegeneral principles of the invention. The scope of the invention shouldbe determined with reference to the claims.

As shown in FIG. 1, a female connector 100 and female/female adapter 110have been designed for use with an Implantable Pulse Generator (IPG) 120or similar neurostimulation device. The invention relates to connectionof those devices with stimulation leads 130 or extension leads 140. Asused herein, “lead” may refer to a stimulation lead and/or sensing leadand/or extension lead (sometimes referred to as a lead extension) and/ora part of one or more of these. As shown in FIGS. 2A and 2Brespectively, a female connector 100 and female/female adapter 110 areprovided, each with a body including a lumen 510 (FIGS. 5A and 5B) inwhich one or more contacts 320 (see FIGS. 3, 4, and 6) are provided(e.g., two or more metal rings may be linearly arranged in the resilientbody of female connector 100 or female/female adapter 110). While femaleconnector 100 is capable of coupling one of a variety of differentdesigns of a lead with the pulse generator or other neurostimulationdevice, female/female adapter 110 can be designed for simultaneouslycoupling two or more of the same or different lead constructions.

As shown in FIGS. 3 and 4 respectively, the invention consists of fivemajor components for the connector and adapter: connector body 300 oradapter body 400, clamp ring(s) 310, contacts 320 (e.g., metal rings),connecting wires 330, and wedge tool(s) 340 used for retaining femaleconnector 100 or female/female adapter 110 in the “unlock” position.FIG. 3 shows the proximal end of connector body 300 attached to a lead350. Wires 330 may electrically connect each of contacts 320 tocorresponding contacts on the opposite end of a lead, to correspondingcontacts 320 within the connector body 400 so that electrical connectionmay be established between the contacts and wires of two mating leads,to the electronic circuitry of an IPG, or to other structure to whichelectrical contact with contacts 320 is desired. At least one contact320 is required for the present invention, however any number ofcontacts 320 may be used for the connector 100 or adapter 110 of thepresent invention.

As shown in FIGS. 5A and 5B respectively, connector body 300 and adapterbody 400 form the main part of female connector 100 (FIG. 2A) andfemale/female adapter 110 (FIG. 2B) and are typically made from a softsilastic material or other soft biocompatible material. Connector body300 and adapter body 400 both preferably, but not necessarily, includeat least one niche 500 for a clamp ring 310 (FIG. 7), a lumen 510, and arelief slit 520 along at least a portion of their lengths. Niche 500nests clamp ring 310 (FIGS. 3 and 4) in the appropriate position alongthe length of connector body 300 or adapter body 400, resulting in asubstantially continuous and flush exterior surface of clamp ring 310with connector body 300 or adapter body 400, while preventing clampingring 310 from sliding along the length of connector body 300 or adapterbody 400. Lumen 510 serves as a receptacle for leads. Relief slit 520provides space that is compressed by connector body 300 or adapter body400 when female connector 100 or female/female adapter 110 is engagedwith a lead, clamp ring(s) 310 are in place, and wedge tool(s) 340 areremoved.

As shown in FIG. 6, contacts 320, such as metal rings, may be made fromplatinum, platinum/iridium or other low resistance biocompatible metalor alloy. Contacts 320 may be spaced within connector body 300 oradapter body 400 to line up with the contacts of the lead when the leadis inserted. Contacts 320 as shown in the example of FIG. 6 are formedof a split, tubular body.

As shown in FIG. 7, clamp ring 310 is made from a biocompatible materialsuch as a hard metal or polymer, for example, titanium, a titanium alloy(i.e., Ti 6/4), stainless steel, polyetheretherketone, or other materialcapable of achieving the purpose of clamp ring 310. The purpose of theclamp ring 310 is to act as a spring, which compresses contacts 320(FIGS. 6, 3, and 4) against the contacts of the inserted lead. Connectorbody 300 and adapter body 400 are, e.g., silastic tubes that insulateclamp ring 310 from contacts 320. Clamp ring 310 in the example shown isa tubular body (while other suitable shapes are possible and fall withinthe scope of the invention), preferably with notches 700 on either endof a slit 710.

Notches 700, or other similar means, provide an entrance for wedge 340to re-open clamp ring 310, thereby permitting leads, female connector100 and female/female adapter 110 to be removable, reusable, andreplaceable. Clamp ring 310 may be re-opened by aligning wedge end 800(FIG. 8) with notches 700 and manually sliding wedge 340 in a directionparallel with slit 710 until wedge 340 has fully opened slit 710. Duringthis process, a surgeon may use her or his hands to secure connector 100or adapter 110 and provide counter-pressure to the force of wedge 340while it is being inserted. Alternately, a surgeon may use anycompatible tool, such as a pair of plyers with modified tips thatresemble wedge end 800 and are capable of dividing slit 710 in a similarmanner as wedge 340 but at both ends of connector 100 or adapter 110simultaneously. Thus, the plyers or other tools would provide neededcounter-pressure on clamp ring 310 so as to alleviate the need for asurgeon to manually provide such counter pressure. It is advantageous tobe able to re-open clamp ring 310 for a patient who, for example, fiveyears after an original surgery, must receive a new IPG to replace theoriginal IPG in the patient's body. The IPG can be easily replacedwithout disturbing the positioning of its associated stimulation orsensing lead simply by detaching the IPG's associated connector oradapter by sliding wedge 340 between notches 700 thereby opening femaleconnector 100 or female/female adapter 110, removing the original IPG,inserting the new IPG, and closing female connector 100 or female/femaleadapter 110 by removing wedge 340.

As shown in FIG. 8, wedge 340 is made from a titanium, hard polymer, orother biocompatible material and its function is to retain clamp ring310 in the “unlocked” position with a wedge end 800 until a lead isinserted into female connector 100 or female/female adapter 110. Asurgeon removes wedge end 800 from slit 710 (FIG. 7) by holding a handle810 and pulling wedge 340 from slit 710 in a direction perpendicular toslit 710 or sliding wedge 340 out of slit 710 in a direction parallelwith slit 710. The surgeon may use her or his fingers or any otherhelpful tool, such as a pair of plyers, to secure connector 100 oradapter 110 while wedge 340 is removed from slit 710.

As shown in the example of FIGS. 9A-9D, a lead connector 900 is engagedwith female connector 100 through several simple steps and does not needthe use of any sophisticated or additional tools. FIG. 9A shows a femaleconnector 100 assembly ready for lead connector 900 insertion. FIG. 9Bshows a lead 910 inserted into female connector 100. To ease leadconnector 900 into connector lumen 510 (FIG. 9A), distilled water orother suitable substance can be used as a lubricant. FIG. 9C shows wedge340 detached from compressed clamp ring 310. Removing wedge 340 releasesthe compressive energy of clamp ring 310 against connector body 300 andcauses the female connector 100 assembly to lock around the leadconnector 900. This action ensures the electrical connection between thecontact surface(s) of the lead connector 900 and the contact(s) 320(FIGS. 3 and 4) within the connector or adapter. The compressed body 300of the connector presses the lead connector 900 with sufficient strengthto prevent it from pulling out of female connector 100. FIG. 9D showslead 910 electrically and mechanically engaged with female connector100.

A similar exemplary method of engagement of FIGS. 9A-9D is shown inFIGS. 10A-10D for a female/female adapter 110, adapter body 400, twowedges 340, two leads 910, and two lead connectors 900. As explainedabove, female/female adapter 110 may accommodate two similar ordissimilar lead 910 designs.

To successfully insert and engage a lead with female connector 100and/or female/female adapter 110, a lead insertion apparatus isused—described above as wedge tool 340. Wedge tool 340 is preferably,but not necessarily, factory-placed into slit 710 (FIG. 7) of clamp ring310. With wedge tool 340 in slit 710, connector body 300 or adapter body400 can be easily slid, perhaps with the use of lubricant such asdistilled water, into place in the lumen of clamp ring 310. Clamp ring310 remains in the “open” position until a lead connector 900 isinserted and ready for engagement with female connector 100 orfemale/female adapter 110. Lead connector 900 is inserted so that thecontacts of the lead connector 900 are aligned with their correspondingcontacts 320 inside the body of the female connector 100 orfemale/female adapter 110.

Preferably, the respective lumen 510 of the female connector 100 orfemale/female adapter 110 contains structure adapted to stop theinsertion of a particular lead connector 900 so that the contacts of thelead connector 900 and the contacts 320 are properly aligned when thelead connector 900 is fully inserted. The dimensions of the stoppingstructure in each lumen 510 may vary depending on the structure of theparticular type of lead connector inserted and the orientation of thecontact(s) on that lead connector. For example, the embodiment of thefemale/female adapter 110 shown in FIGS. 10A-10D may include silasticstopping structure in the center of lumen 510, thus dividing the lumenin half so that each lead connector 900 may be fully inserted until theend of the respective lead connector 900 is blocked by the silasticstopping structure. The appropriate amount of stopping structure usedwould force the contacts of a fully inserted lead connector 900 to beperfectly aligned with corresponding contacts 320 on the respective endof the female/female connector 110.

After lead connector 900 insertion, wedge 340 is detached from clampring 310 (as discussed previously with reference to FIGS. 7 and 8) andlead 910 becomes electrically engaged with female connector 100 orfemale/female adapter 110.

FIG. 11 shows a female connector 100 attached to an IPG 120.

FIG. 12 shows a lead extension 1200 which includes a female connector100, a lead extension body 1210, and a lead connector 900.

FIG. 13 shows a female/male adapter 1300, which includes a femaleconnector 100 and a lead (or device) connector 900.

FIG. 14 shows a female/female adapter 110. An alternate embodiment of anadapter, a male/male connector, is not shown but is considered part ofthe present invention. The male/male connector includes two leadconnectors 900 at either end of the male/male connector. Further, aswith all connectors and adapters of the present invention, female/femaleadapter 110 is capable of receiving any design of lead at either end offemale/female adapter 110. Likewise, female/female adapter 110 can bemodified to receive and connect to any number of leads or leads withmultiple branches as, for example, in a “Y-shaped”, “H-shaped”, or“W-shaped” configuration. In these cases, multiple wires 330 (see FIG.4) are attached and properly directed to and from contacts 320, somewires 330 of which may be split at an appropriate point along thepathway between contacts 320.

While the invention herein disclosed has been described by means ofspecific embodiments and applications thereof, numerous modificationsand variations could be made thereto by those skilled in the art withoutdeparting from the scope of the invention set forth in the claims.

1. A lead connector for use with a medical device, comprising: a bodydefining at least one lumen between a proximal end of the body and adistal end of the body, the distal end of the body being configured toreceive and engage with a lead, and the proximal end of the body beingconfigured for attachment to an Implantable Pulse Generator (IPG); atleast one niche along an outside surface of the body; at least onecontact along the at least one lumen of the body; at least one wire,electrically connected to the at least one contact; and at least oneclamp ring capable of nesting within the at least one niche, wherein theat least one clamp ring defines at least one slit along at least aportion of its length.
 2. The connector of claim 1, further comprisingat least one wedge.
 3. The connector of claim 2, wherein the at leastone clamp ring is opened when the at least one wedge is engaged with theat least one slit of the at least one clamp ring.
 4. The connector ofclaim 2, wherein the at least one clamp ring is closed when the at leastone wedge is removed from the at least one slit of the at least oneclamp ring.
 5. The connector of claim 1, wherein the at least one clampring defines at least one notch at at least one end of the at least oneslit of the at least one clamp ring.
 6. The connector of claim 1,further comprising at least one relief slit along at least a portion ofthe body.
 7. The connector of claim 6, wherein the at least one reliefslit extends along an entire length of the body.
 8. The connector ofclaim 1, wherein the body is constructed of a soft biocompatiblematerial and the clamp ring is constructed of a hard polymer.
 9. Theconnector of claim 1, wherein the slit of the clamp ring extends alongan entire length of the clamp ring.
 10. The connector of claim 1,wherein the clamp ring is configured and arranged to at least partiallysurround the body.
 11. The connector of claim 2, wherein the clamp ringis configured to assume an opened position when the wedge is engagedwith the slit of the clamp ring, wherein the lead is configured to beremoved from the lumen of the body when the clamp ring is in the openedposition.
 12. The connector of claim 2, wherein the clamp ring isconfigured to compress into a closed position when the wedge is removedfrom the slit of the clamp ring, said compression being configured tocompress the at least one contact along the lumen of the body against atleast one contact of the lead.
 13. A stimulation system comprising theconnector of claim 1, an implantable pulse generator, and a lead coupledto the implantable pulse generator via the lead connector.
 14. A leadconnector comprising: a body defining at least one lumen between aproximal end of the body and a distal end of the body, the distal end ofthe body being configured to receive and engage with a lead, and theproximal end of the body being configured for attachment to anImplantable Pulse Generator (IPG); a clamp ring having a slit along atleast a partial length thereof, wherein the clamp ring is configured toat least partially surround the body; and a wedge configured toremovably fit within the slit of the clamp ring, wherein the clamp ringis configured to compress into a closed position when the wedge isremoved from the slit of the clamp ring, said compression beingconfigured to compress the body against the lead.
 15. The connector ofclaim 14, wherein the clamp ring is configured to assume an openedposition when the wedge is engaged with the slit of the clamp ring,wherein the lead is configured to be removed from the lumen of the bodywhen the clamp ring is in the opened position.
 16. The connector ofclaim 14, further comprising at least one electrical contact disposedwithin the lumen of the body.
 17. The connector of claim 16, wherein theat least one electrical contact is configured to be compressed against acorresponding electrical contact disposed on the lead when the clampring is in the closed position.
 18. The connector of claim 14, furthercomprising a relief slit along at least a portion of the body.
 19. Theconnector of claim 14, wherein the slit of the clamp ring extends alongan entire length of the clamp ring.
 20. A stimulation system comprisingthe connector of claim 14, an implantable pulse generator, and a leadcoupled to the implantable pulse generator via the connector.